Many cancer patients in phase I clinical trials are treated at doses of chemotherapeutic agents that are below the biologically active level, thus reducing their chances for therapeutic benefit. Present the advantages and drawbacks of the various dose escalation methods and discuss specific applications of the methods We also describe specific methods for drugĬombinations as well as methods that use a time-to-event endpoint or both toxicity and efficacy as endpoints. In tumor or surrogate tissues, have been proposed along with new trial designs. ![]() Potential alternative endpoints to delineate optimal biological activity, such as plasma drug concentration and target inhibition However, with the emergence of molecularly targeted anticancer agents, Toxicity has traditionally been the primaryĮndpoint for phase I trials involving cytotoxic agents. ![]() ![]() ![]() Here we review dose escalation methods for phase I trials, including the rule-based and model-basedĭose escalation methods that have been developed to evaluate new anticancer agents. The guiding principleįor dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safetyĪnd maintaining rapid accrual. The main goal of these studies is toĮstablish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. Phase I clinical trials are an essential step in the development of anticancer drugs.
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